E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Palliative patients with recurrent and/or metastatic head and neck cancer after failure of first line standard chemotherapy. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025055 |
E.1.2 | Term | Lung cancer non-small cell stage IV |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
-Determine the efficacy of CP-751,871 alone in patients with head and neck cancer in term of overall response rate |
|
E.2.2 | Secondary objectives of the trial |
-Determine the safety profile of CP-751,871 alone in patients with head and neck cancer -Determine the efficacy of CP-751,871 alone in patients with head and neck cancer:progression-free survival and survival. -To perform translational research |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-recurrent and or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation. -recurrence must be confirmed by anatomopathology(cytology or biopsy) -at least one measurable lesion by MRI or CT-scan -failed or relapsing after first line chemotherapy including a platinum or a taxane-based chemotherapy regimen -patients ineligible for chemotherapy could be included in first line -ECOG performance status 0-2, in stable medical condition -Patients must have an expected survival of at least 3 months -paraffin-embedded tumor tissue available for immunohistochemistery -patients must be over 18 years old and must be able to give written inform consent. |
|
E.4 | Principal exclusion criteria |
-non-squamous head and neck cancer -nasopharynx cancer -brain metastases -more than two lines of chemotherapy for palliative treatment(except if chemotherapy was given as a part of a multimodal treatment given with a curative intent) -surgery or irradiation or investigationnal drugs within 4 weeks before study inclusion -prior anti-IGF-1R therapy -other concomitant anti cancer therapy -other uncontrolled illnesses |
|
E.5 End points |
E.5.1 | Primary end point(s) |
-Determine the safety profile of CP-751,871 alone in patients with head and neck cancer -Determine the efficacy of CP-751,871 alone in patients with head and neck cancer:progression-free survival and survival. -To perform translational research |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of the study occurs at the last patient's last visit |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |